Hyperpure chlorine dioxide versus chlorhexidine in intra-oral halitosis (ODOR trial) - protocol of a double-blinded, double-arm, parallel non-inferiority pilot randomized controlled trial.

IF 2.5 Q2 DENTISTRY, ORAL SURGERY & MEDICINE BDJ Open Pub Date : 2024-05-20 DOI:10.1038/s41405-024-00221-8

Eszter Ágnes Szalai, Brigitta Teutsch, Viktória Babay, Adél Galvács, Péter Hegyi, Péter Hársfalvi, Róbert Pál, Gábor Varga, Zsolt M Lohinai, Beáta Kerémi

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Abstract

Introduction: Intra-oral halitosis (IOH) is the most common type of bad breath; its consequences impair quality of life. However, evidence-based treatment protocols and guidelines are lacking. Our aim is to investigate the effectiveness of chlorine dioxide as an applicable complementary treatment modality in IOH after tongue cleaning.

Methods and analysis: The ODOR trial will be a single-center, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. We plan to investigate the short-term effects of the intervention over a 3-h period. The primary endpoint will be changes in organoleptic test scores. At the end of the pilot investigation of the first 30 patients each, sample size calculation will be performed. If feasible, the investigators will continue the study by enrolling more patients.

Trial registration: The trial has been registered at ClinicalTrials.gov (NCT06219226).

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超纯二氧化氯与洗必泰治疗口内口臭（ODOR 试验）--双盲、双臂、平行非劣效性随机对照试验方案。

简介口内口臭（IOH）是最常见的口臭类型，其后果会影响人们的生活质量。然而，目前还缺乏循证治疗方案和指南。我们的目的是研究二氧化氯作为一种适用于舌清洁后口腔内口臭的辅助治疗方式的有效性：ODOR试验将是一项单中心、双盲、平行组、双臂试验性随机对照试验，采用非劣效性设计。超纯二氧化氯的功效将与洗必泰漱口水进行比较。我们计划在 3 小时内调查干预措施的短期效果。主要终点是感官测试评分的变化。在对首批各 30 名患者的试点调查结束后，将对样本量进行计算。如果可行，研究人员将招募更多患者继续研究：试验已在 ClinicalTrials.gov (NCT06219226) 上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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